EUCTR2012-004878-26-SE
Active, not recruiting
Phase 1
Antibiotic prophylaxis in patients undergoing primary or secondary breast reconstruction with implants, a randomized parallel two armed prospective clinical trial.
Karolinska University Hospital Solna0 sites870 target enrollmentNovember 9, 2012
DrugsKloxacillin 2g OR
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Karolinska University Hospital Solna
- Enrollment
- 870
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Women \>18 years old
- •Present diagnosis or a history of breast cancer
- •Elective surgery with primary or secondary first\-time breast reconstruction with implants.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 780
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 90
Exclusion Criteria
- •Unable to understand Swedish language
- •Allergy to any of the study drugs (Kloxacillin/Klindamycin)
Outcomes
Primary Outcomes
Not specified
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